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Non-Pharmacological Methods in Heel Lance

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Study completion pushed from May 15, 2026 to Jun 15, 2026
    • Site details revised
    v3
  2. Start date: Dec 25, 2025 to Feb 25, 2026v2 Show 4 more changesShow less
    • Primary completion date: Jan 30, 2026 to Feb 25, 2026
    • Study completion date: Feb 15, 2026 to May 15, 2026
    • Study description shortened, about 40 words
    • Eligibility criteria shortened, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care. Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.
Trial Details
NCT Number NCT07348731
Lead Sponsor Atlas University
Conditions
(from sponsor)		 Heel Lance Procedures
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov